Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Prostatic Neoplasms

Prostatic Neoplasms, Castration-Resistant

Disease Attributes

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Anticoagulants

Bone Density Conservation Agents

Gallium 68 PSMA-11

Edetic Acid

Pentetic Acid

Chelating Agents

Calcium

Calcium, Dietary

Radiopharmaceuticals

Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.

Ga-68 PSMA-HBED-CC PET

Michael M Graham, Ph.D., MD

This study investigates if a new drug (PSMA) makes prostate cancer easier to identify in positron-emission tomography (PET) imaging. If this works, prostate cancer treatments can be prescribed that match the location of the disease. PSMA is radiolabeled with Gallium-68 (Ga-68). This means a participant receives a small dose of radiation from the drug - less than the annual radiation limit for a medical worker.

To test this new drug, participants will receive an injection of Ga-68 PSMA and then have a PET scan. This PET scan, and the reported results, will be entered into the medical record and shared with the treating oncologists.

This study evaluates PSMA-HBED-CC labelled with Gallium-68, abbreviated 68Ga PSMA. This is a radiotracer that attaches to receptors in the membrane of prostate cancer cells. The 68Ga PSMA is identified using a positron emission tomography (PET) scanner. It is believed that 68Ga PSMA will identify prostate cancer more precisely than normal imaging methods (MRI, CT, or ultrasound). Imaging is key to successful treatment - disease must be identified to be treated.

The 68Ga PSMA will be tested in men who have biochemical recurrence of prostate cancer after surgery or radiation treatment. Participants undergo the 68Ga PSMA PET scan before further treatment. Clinical information, including any MRI, CT, or ultrasound imaging and biopsy/surgery information, will be used to determine if the 68Ga PSMA PET imaging was better than the standard imaging. The study team will collect this information for about 1 year after the PSMA scan.

Depending on findings, participants may be invited back for a second 68Ga PSMA scan. This is done if the first scan showed positive lymph nodes or soft tissue metastases but a surgery or biopsy result does not.

The results from these scans will be shared with the participant. Results will also be entered into the participant's medical record and shared with the treating oncologists.

Evaluating the Clinical Accuracy of Gallium-68 PSMA PET/CT Imaging in Patients With Biochemical Recurrence of Prostate Cancer

Clinical Accuracy Assessment of 68Ga PSMA-HBED-CC PET in Patients With Biochemical Recurrence

Codified data will be archived and stored in an imaging repository with limited metadata for analysis. A data sharing contract for a HIPAA limited dataset will need to be executed prior to data sharing.

Sensitivity will be determined on a per-patient basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.

Sensitivity will be determined on a per-region basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.

Positive predictive value will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.

Sensitivity value will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.

Detection rates will be evaluated on a per-subject basis, stratified by PSA values: 0.2 - \<0.5, 0.5 - \<1.0, 1.0 \<2.0, 2.0 - \<5.0, 5.0 or greater

Adverse events will be determined through clinical assessment and categorized by CTCAE 4.03

Spots Global Cancer Trial Database for nuclear scans